Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for 12 years and older.
Except for the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, all other vaccine components remain unchanged.
Preclinical data showed that a booster dose of omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against omicron subvariants.
The companies have also provided safety data from clinical trials evaluating multiple variant-adapted vaccine candidates based on previous variants of concern.
Pfizer and BioNTech also applied with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July, which is currently under review by the Agency. The Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September.
Price Action: PFE shares are down 1.39% at $47.24, and BNTX stock is down 2.05% at $145.52 on the last check Friday.
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